FDA.report

Flouroscan InSight

Primary DI
15420045509641
Brand
Flouroscan InSight
Company
Hologic, Inc.
Model
System Software
Catalog number
InSight FD
Published
2018-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OXOImage-intensified fluoroscopic x-ray system, mobile

Product Code Classifications

CodeDeviceSpecialtyClass
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15420045509641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1542004550964115420045509641

GMDN Terms

TermDefinition
Portable general-purpose fluoroscopic x-ray system, digitalA portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.

Sterilization Methods

Method

Regulatory Flags

DUNS number
139534114
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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15420045518162Selenia® Dimensions®ASY-10775-3D-UPSASY-10775-3D-UPS2026-03-12
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15420045518193Selenia® Dimensions®ASY-10775-3D-CNASY-10775-3D-CN2026-03-12
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15420045518223Selenia® Dimensions®ASY-08483-3D-CNASY-08483-3D-CN2026-03-12
15420045518230Selenia® Dimensions®ASY-08483-2D-CNASY-08483-2D-CN2026-03-12
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15420045518261Affirm Prone Biopsy SystemPBX-SYS-AFFIRM-2D-CNPBX-SYS-AFFIRM-2D-CN2026-03-12
15420045518278Affirm Prone Biopsy SystemASY-06886-CNASY-06886-CN2026-03-12
15420045518285Affirm Prone Biopsy SystemASY-09175-CNASY-09175-CN2026-03-12
15420045518292Affirm Prone Biopsy SystemASY-08832-CNASY-08832-CN2026-03-12
15420045516236EnvisionASY-14621ASY-146212025-11-13
15420045516243EnvisionASY-14622ASY-146222025-11-13
15420045516250EnvisionASY-14623ASY-146232025-11-13
15420045516267EnvisionASY-14624ASY-146242025-11-13
15420045516274EnvisionASY-14625ASY-146252025-11-13

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